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Clinical trials in optometry are becoming one of the most important pathways for advancing patient care, expanding treatment options, and helping eye care professionals shape the future of the profession. A recent episode from one of the top optometry podcasts explored how clinical research is evolving, why more optometrists are becoming principal investigators, and how practices can begin participating in clinical trials.

Featuring insights from Dr. Carol Aune, the conversation focused on real-world clinical research, innovation in eye care, AI integration, myopia control, cataract treatment development, and how practices can become involved in research without completely stepping away from patient care.

Key Takeaways

• Clinical trials are creating new opportunities for optometrists to become principal investigators instead of only sub-investigators.
• Research participation can help patients gain access to treatments that are not yet commercially available.
• AI, personalized medicine, and cataract treatment drops are emerging trends shaping the future of clinical trials in eye care.

Why Clinical Trials in Optometry Matter

Every Treatment Starts With Research

Every medication, contact lens, ophthalmic drop, and device used in eye care must go through the clinical trial process before reaching patients. According to Dr. Carol Aune, clinical trials are necessary if the profession wants continued innovation in treatment options.

For years, ophthalmologists were often the primary investigators leading eye care clinical trials. That changed when FDA requirements evolved, allowing qualified optometrists with the proper experience and training to become principal investigators.

“We are the ones prescribing these treatments, so we should be the ones researching these treatments as well.” — Dr. Carol Aune

That shift has opened the door for more optometrists to play a direct role in advancing patient care through research participation.

How to Get Started in Clinical Trials

Building Experience as a Sub-Investigator

One of the biggest questions discussed during the episode was how an optometrist can actually enter the world of clinical research.

Dr. Carol Aune explained that many eye care professionals begin as sub-investigators before transitioning into leadership roles within research.

Common Entry Points Into Clinical Research

• University-based research programs
• Academic medical centers
• Hospital systems
• Corporate optometry organizations
• Existing clinical research teams
• Local research networks

She also emphasized that many optometry schools already expose students to research opportunities.

Educational Note

Research participation does not always begin with running a study independently. Many optometrists first gain exposure by assisting on active studies or working alongside experienced coordinators and investigators.

Understanding the Role of a Clinical Research Team

Clinical trials are not solo projects. Successful studies require an organized team structure.

Core Team Members Often Include:

• Principal investigator
• Sub-investigators
• Clinical research coordinators
• Regulatory support staff
• Study participants
• Sponsors or pharmaceutical companies

Dr. Carol Aune noted that experienced coordinators are especially important during the startup phase because sponsors want confidence that protocols will be followed correctly.

Why Protocols Matter

Clinical research operates on strict timelines and standardized assessments. Study visits often include precise testing windows, documentation requirements, and regulatory oversight.

Some visits may require:

• Hour-zero evaluations
• Timed follow-ups
• Imaging assessments
• Data transcription
• Adverse event monitoring
• Regulatory documentation

This level of structure ensures patient safety while maintaining accurate data collection.

The Real Cost of Starting Clinical Trials

One of the most valuable parts of the conversation was the transparency around workload and startup expectations.

Dr. Carol Aune explained that many optometrists already own the majority of the equipment needed for ocular clinical trials.

Typical Equipment Already Found in Practices

• Slit lamp
• Diagnostic imaging devices
• Visual acuity systems
• Dry eye testing tools
• Contact lens fitting equipment

The primary investment often comes from staffing and time allocation.

Coordinator Costs

Experienced research coordinators may earn approximately:

• $65,000–$95,000 annually depending on experience
• Part-time arrangements may be possible for smaller studies

Direct Transcript Insight

Dr. Carol Aune shared that when she first entered research, she often arrived early, worked through lunch, and stayed late to manage study participants while still maintaining a full clinical schedule.

That reality highlights the level of commitment required to build a successful research program.

Clinical Trials as a Patient Care Opportunity

Helping Patients Access Emerging Treatments

One of the strongest patient experience themes throughout the episode was the idea that clinical trials can become treatment opportunities for patients who may not respond well to existing therapies.

Areas Seeing Significant Research Activity

• Dry eye disease
• Blepharitis
• Presbyopia
• Myopia control
• Cataract treatment
• Ocular surface disease

Educational Insight

Clinical trials may provide access to therapies years before they become commercially available.

For patients struggling with chronic dry eye or progressive myopia, participation in a study may offer additional treatment pathways that would otherwise be unavailable.

AI in Clinical Trials and Oculomics

Artificial intelligence is beginning to influence clinical trials in eye care, although Dr. Carol Aune explained that implementation is still early.

Currently, many imaging assessments are reviewed manually by centralized reading centers to maintain grading consistency.

Potential AI Applications in Research

• Corneal staining analysis
• Automated image grading
• Data transcription support
• Electronic source integration
• Clinical workflow efficiency

“If an AI could just take our eSource and just make it match their platform seamlessly, then that would be great.” — Dr. Carol Aune

The discussion also touched on oculomics and how ocular imaging could potentially help identify systemic disease patterns in the future.

Personalized Medicine and Future Innovation

One of the most exciting sections of the conversation focused on personalized medicine. Dr. Carol Aune discussed studies involving genotype-specific therapies where treatments may only work for patients with certain genetic markers.

Emerging Innovation Areas in Clinical Trials in Eye Care

Personalized Medicine

Researchers are studying therapies targeted to specific genetic profiles rather than using one treatment approach for every patient.

DNA Repair and Wound Healing

New biologic therapies are being evaluated to support wound healing through DNA repair mechanisms instead of only targeting inflammation.

Cataract Treatment Drops

One of the most discussed innovations involved investigational cataract drops.

While Dr. Carol Aune noted these drops may not replace cataract surgery entirely, they could potentially:

• Delay surgery progression
• Improve access to care
• Support underserved communities
• Help patients in remote locations
• Provide temporary visual improvement

Educational Perspective

Access to cataract care remains a major healthcare challenge globally, making pharmaceutical treatment options an area many eye care professionals are watching closely.

Diversity in Clinical Trials

The episode also explored the importance of diversity in clinical research participation.

Dr. Carol Aune explained that community engagement plays a major role in building trust and reducing stigma surrounding clinical trials.

Strategies That Improve Diversity in Research

• Community outreach events
• Health fairs
• Vision walks
• Local education efforts
• Relationship building
• Transparent communication

Educational Insight

Building trust within communities helps patients better understand that clinical trials are focused on advancing care and improving outcomes rather than experimentation.

How Eye Care Professionals Can Learn More

For eye care professionals interested in participating in research, Dr. Carol Aune recommended exploring:

• ClinicalTrials.gov
• Local hospital systems
• Academic institutions
• Existing research teams
• Corporate research programs

She also emphasized the importance of networking and mentorship within the clinical research community.

Final Thoughts on Clinical Trials in Optometry

Clinical trials in optometry continue to create opportunities for eye care professionals to shape the future of patient care while expanding access to innovation. Whether through dry eye therapeutics, myopia control, AI integration, or personalized medicine, research participation is becoming increasingly important within the profession.

For practices considering involvement, one of the best first steps is identifying ongoing studies in your region and connecting with experienced research teams. Even starting as a sub-investigator can provide valuable exposure and open doors for future leadership opportunities in research.

Looking to stay ahead in eye care, leadership, patient experience, and innovation? Follow Defocus Media, the #1 optometry podcast network, for conversations designed to help eye care professionals grow clinically, professionally, and personally.